US8162873B2 - Apparatus for administering a therapeutic agent into tissue - Google Patents
Apparatus for administering a therapeutic agent into tissue Download PDFInfo
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- US8162873B2 US8162873B2 US12/430,740 US43074009A US8162873B2 US 8162873 B2 US8162873 B2 US 8162873B2 US 43074009 A US43074009 A US 43074009A US 8162873 B2 US8162873 B2 US 8162873B2
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- ozone
- therapeutic agent
- generator
- administrator
- oxygen
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3478—Endoscopic needles, e.g. for infusion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/40—Peroxides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M2005/3114—Filling or refilling
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M2005/3128—Incorporating one-way valves, e.g. pressure-relief or non-return valves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/02—Gases
- A61M2202/0208—Oxygen
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/02—Gases
- A61M2202/0216—Ozone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2210/00—Anatomical parts of the body
- A61M2210/10—Trunk
- A61M2210/1003—Spinal column
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/065—Guide needles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
Definitions
- the present invention relates generally to a method, apparatus and kit for administering a therapeutic agent into tissue and in particular, for the administration of a therapeutic agent such as medical ozone.
- Back joint disc or tendon pain is a common and potentially debilitating ailment that affects an estimated 80% of the worldwide population at least once in a lifetime.
- the cause of the pain can be attributed to a degenerated intervertebral disc that has further deteriorated into a condition known as disc herniation. This occurs when the disc nucleus pulposus extrudes through a tear or fissure in the outer lining of the disk, thereby exerting pressure on spinal nerves.
- the compression caused by the herniated nucleus leads to inflammation and is directly responsible for the pain felt down the leg (also referred to as sciatica).
- Available treatments for this type of back pain vary according to the severity of the hernia.
- inflammation can develop between two surfaces the are involved in allowing joint function, such as a tendon and the sheath or lubricated tube in which that tendon moves.
- Inflammation such as bursitis in the knee shoulder hip, or other anatomic bursa may benefit from ozone therapy; this includes epicondylitis, and other tendonitis and bursitis, including the wrist, hand and the tendon sheaths of the hand and wrist. Inflammation can occur at a site where a tendon or a ligament insert to bone or pass through a sheath from trauma, tension, over use or disease.
- Inflammation can develop through pathologies of any joint, and these may again include the inflammatory arthropatic conditions of rheumatoid arthritis, psoriatic arthritis and the like, or osteoarthritis.
- Joints that may be involved in these processes that are amenable to ozone injection include the synovial joints such as the, temperomandibular joint, the hip joint, knee joint, ankle joint, elbow joint or sacro-iliac joint.
- Vertebral facet and sacro-iliac joints may also benefit, inflammatory involvement of joints in the hand, wrist and feet with rheumatoid arthritis, osteoarthritis or a repetitive injury through sports or occupational such as carpal tunnel syndrome.
- ibuprofen a combination of anti-inflammatory agents such as ibuprofen, or more powerful drugs such as steroids or chemotherapy such as methotrexate. It is a common medical practice to inject steroid medications or lidocaine directly into the inflamed tissue or joint. This is often done repeatedly. These drugs can be associated with side effects of infection and even death from gastric ulcer bleeding or immunosurpression and infection. We believe that ozone therapy whether as a liquid or a gas would have advantages over the current practice.
- Lavage of a surgical space prior to placement of a permanent surgical implant such as a hip or knee prosthesis, or pacemaker or treatment of an infected joint can be facilitated by the use of medical ozone as a sterilizing substance.
- a colostomy stoma can be created such that the adhesive disk is infused with ozone as a liquid or gas to aid in healing and inhibit infection.
- the post surgical recovery from sternotomy after cardiac surgery is often complicated wound infection. Placement of a resorbable catheter in the wound that could be irrigated with ozone liquid or gas would aid healing. Indeed any wound could have a resorbable multisided hole catheter placed in it to allow ozone be injected through it. This would have anti-infective, analgesic and promote wound healing properties. This would shorten recovery time and decrease complication rates after surgery.
- Enhance liquid ozone could be applied to the wound/surgical site healing at a site of high probability of infection such an abdominal incision/wound after appendectomy, or urgent colectomy with colostomy or after percutaneous endoscopic cholecystectomy.
- Endoscopic procedural infusion of ozone and trans catheter infusion of ozone can be used to inhibit the complications endoscopic medical intervention or image guided or non-image guided catheter based intervention for example in endoscopic evaluation of the pancreatic duct.
- Dental injection of liquid or gas ozone may augment the preparation and repair of dental cavities, and aid in reduction of root canal inflammation or periodontal disease.
- kits for intervention in inflammatory and degenerative disease that are disposable, or reusable, but aid in creating sterile, stable, ozone rapidly on demand.
- the generation of ozone from sterile water would allow storage of injector/generators in all medical dental and veterinary facilities.
- kits for administering therapeutic gas mixture into soft tissue wherein said gas mixture includes ozone.
- the kit can comprise of the following items:
- An example of a local anesthetic is, but not limited to, Lidocaine HCl
- nonionic x-ray dye is, but not limited to, Omnipaque 300 M.
- An example of a post-operative dressing is, but not limited to, Povidone gel.
- Any suitable source of ozone can be used such as an ozone generator, the AOS-1M Medical Ozonator or AOS-1MS Stainless Medical Ozonator for example, or a disposable injector filled with ozone.
- a method for the treatment of pain caused by a herniated disc comprising of first identifying the herniated disk using an imaging technique and subsequently injecting a known volume of medical ozone into the disc and paraspinous soft tissues in a sterile manner and environment.
- an apparatus for administering a therapeutic agent comprising a therapeutic agent generator and a scavenger connected to the generator via a first valve for capturing the therapeutic agent.
- the therapeutic agent administrator is connectable to the generator via at least one additional valve such that when the valves are in a first position the generator communicates with the administrator for filling the administrator with the agent. When the valves are in a second position the administrator retains the agent therein upon disconnection from the generator, and the scavenger captures any excess agent intermediate the administrator and the generator.
- the agent can be ozone in a gaseous mixture or dissolved in a liquid.
- the generator can be a medical ozone generator.
- the medical ozone can be a ratio of oxygen (O2) and ozone (O3).
- the ratio of ozone in micro grams to oxygen in milliliters can be about 1 ⁇ g/ml, or about 10 ⁇ g/ml, or about 20 ⁇ g/ml, or about 30 ⁇ g/ml, or about 40 ⁇ g/ml, or about 50 ⁇ g/ml.
- the ratio of ozone in micro grams to oxygen in milliliters can be between about 1 ⁇ g/ml and about 90 ⁇ g/ml.
- the ratio of ozone to oxygen can be between about 10 ⁇ g/ml and about 80 ⁇ g/ml.
- the ratio of ozone to oxygen can be between about 20 ⁇ g/ml and about 70 ⁇ g/ml.
- the ratio of ozone to oxygen can be between about 10 ⁇ g/ml and about 34 ⁇ g/ml. More preferably, the ratio of ozone to oxygen can be between about 27 ⁇ g/ml to about 28 ⁇ g/ml.
- the administrator can be a syringe.
- Another aspect of the invention provides a method of treating the pain caused by a herniated disc comprising identifying the herniated disk and injecting medical ozone into the disc and paraspinous soft tissues.
- a syringe for self-contained generation and administration of a therapeutic agent comprising a barrel for holding the agent, and a plunger for insertion into a first end of the barrel and expressing the agent from a second end of the barrel.
- the syringe also includes a power supply integrally mounted coaxially with the plunger.
- the syringe also includes a therapeutic agent generator integrally mounted coaxially with the plunger and in communication with the barrel through a channel in the plunger. The generator is connected to the power supply and mounted coaxially with the plunger.
- the syringe also includes a switch connected to the power supply such that when the switch is activated the therapeutic agent generator generates the therapeutic agent and fills the barrel therewith.
- the ozone can be generated either as a liquid or a gas, in a syringe type structure where the electronics are housed in the area normally occupied by the plunger of the syringe and the anode is in the syringe.
- the syringes can be any desired volumes, such as those ranging from 1 cc to 60 cc, more preferably 1 cc to 10 ccs.
- the syringes are typically made of polyethylene to resist the corrosive effect of ozone even in the short time it in contact with the plastic.
- an implantable apparatus for self-contained generation and administration of a therapeutic agent comprising: a chamber for holding the agent and a catheter for connecting the chamber to an area for administration of the agent.
- the apparatus also includes a power supply and a therapeutic agent generator in communication with the chamber, the generator connected to the power supply.
- the apparatus also includes a switch activatable externally by a patient implanted with the apparatus. The switch is connected to the power supply such that when the switch is activated the therapeutic agent generator generates the therapeutic agent and fills chamber therewith.
- Another aspect of the invention provides a method of treating pain caused by a herniated disc comprising of the following steps:
- FIG. 1 shows an apparatus for administering a gas into a tissue in accordance with an embodiment of the invention
- FIG. 2 shows the hip area of a patient where a therapeutic agent can be administered
- FIG. 3 shows the spinal disc area of a patient where a therapeutic agent can be administered
- FIG. 4 shows a normal spinal disc
- FIG. 5 shows a herniated spinal disc where a therapeutic agent can be administered
- FIG. 6 shows an apparatus for administering a gas into a tissue in accordance with another embodiment of the invention.
- FIG. 7 shows the administrator of FIG. 6 with the needle placed thereon
- FIG. 8 shows an apparatus for administering a gas into a tissue in accordance with another embodiment of the invention.
- FIG. 9 shows an apparatus for administering a therapeutic agent into a hip region in accordance with another embodiment of the invention.
- FIG. 10 shows the apparatus of FIG. 9 in greater detail
- FIG. 11 shows an infusion wire through which a therapeutic agent can be administered
- FIG. 12 shows the infusion wire being passed through a needle towards the centre of a herniated disc
- FIG. 13 shows the infusion wire being placed in centre of a herniated disc with the needle having been removed
- FIG. 14 shows the infusion wire of FIG. 11 in greater detail
- FIG. 15 shows an apparatus for administering a therapeutic agent into a tissue in accordance with another embodiment of the invention.
- apparatus 20 comprises an ozone generator 24 that connects to a charcoal scavenger 28 and an ozone administrator 32 .
- Generator 24 can be based on any known medical ozone generator.
- Generator 24 connects to scavenger 28 and administrator 32 via a network of flexible tubing and valves for selectively directing the flow of gas there between. More specifically, a first segment of tubing 36 connects generator 24 to a three-way valve 40 . A second segment of tubing 44 connects valve 40 to scavenger 28 .
- a third segment of tubing 48 connects valve 40 to another valve 52 , which in turn connects to administrator 32 .
- the tubing is made of any suitable material, such as silicon of the known medical type, and has a diameter and wall thickness to withstand the pressure of ozone gas being carried there through.
- the valves also known as stopcocks, are also of the known medical type and have fittings complementary to the various portions of tubing.
- Administrator 32 is comprised of a syringe 56 , a three-way valve 60 , and a needle 64 .
- Syringe 56 is typically made of polyethylene to resist the corrosive effect of ozone, but other materials will occur to those of skill in the art.
- Three-way valve 60 is releasably connectable directly to valve 52 , providing a selective pathway between syringe 56 and generator 24 and/or scavenger 28 .
- Valve 40 has a first position wherein generator 24 communicates only with tubing 48 .
- Valve 52 has a first position wherein tubing 48 communicates with administrator 32 .
- Valve 60 has a first position wherein syringe 56 communicates only with tubing 48 .
- generator 24 is in communication with syringe 56 , and thus when generator 24 is “on”, syringe 56 will be filled with ozone.
- Valve 40 has a second position wherein tubing 44 communicates with both tubing 36 and 48 .
- Valve 52 has a second position wherein tubing 48 is effectively capped, preventing communication between administrator 32 and tubing 48 .
- scavenger 28 is of the charcoal type, but any type of scavenger for capturing excess ozone can be used.
- generator 24 is turned “off” after filling syringe 56 as described above, then when valves 40 and 52 are each moved from their respective first position to their respective second position then any excess ozone still present in tubing 48 and 36 will be captured by scavenger 28 and thereby reduce and/or substantially eliminate the unwanted escape of ozone into the atmosphere where it may harm the operator or other individuals proximal to apparatus 20 .
- Valve 60 also has a second position wherein syringe 56 is prevented from communicating with either valve 52 (or the open fitting on valve 60 that connects to valve 52 ), or with needle 64 .
- valve 60 will also be placed in its second position to retain the ozone within syringe 56 once administrator 32 is disconnected from valve 52 .
- valve 60 also has a third position that places syringe 56 in communication with needle 64 .
- valve 60 when charged, valve 60 can be placed in the second position to prevent ozone from escaping from syringe 56 .
- Administrator 32 can then be disconnected from the remainder of apparatus 20 and then needle 64 can be inserted into tissue (or other target area) where the ozone is to be administered.
- needle 64 is shown inserted into a hip 68 .
- valve 60 is placed in the third position, allowing syringe 56 to communicate with needle 64 .
- syringe 56 is depressed, and the ozone gas therein is expressed out of needle 64 into hip tissue, thereby providing localized pain relief around hip 68 .
- Such administration of ozone can be helpful to relieve pain after some types of hip surgeries, such as hip replacement, or after bone is harvested from the pelvis to use as a bone graft material.
- FIG. 2 depicts pain relief being provided to hip 68
- FIG. 3 depicts the provision of pain relief to a spinal disc 72 .
- a normal disc is shown in cross section at 72 n .
- Disc 72 n has an outer annulus fibrosus 76 n , an inner annulus fibrosus 80 n , a transition zone 84 n , and a nucleus pulposus 88 n .
- disk 72 is also shown in cross section, wherein nucleus pulposus 88 is protruding, and thereby a cause of pain.
- the administration of ozone into the protruding nucleus pulposus 88 using administrator 32 via needle 64 pain can be relieved and/or substantially eliminated at least temporarily.
- administrator 32 can then be reconnected to the remainder of apparatus 20 , and the appropriate valves 40 , 50 and 62 adjusted to either allow any remaining ozone to be expressed from administrator 32 for capture by scavenger 28 , or to refill syringe 56 .
- Apparatus 20 a includes many similar components to apparatus 20 , and like components are indicated with like references but followed by the suffix “a”.
- administrator 132 a includes certain differences from administrator 32 . Specifically, administrator 132 a has a two way valve 160 a , one end of which connects to syringe 132 a , the other end of which has a fitting to allow administrator 132 a to be connected to either valve 52 a , as shown in FIG. 6 , or to needle 164 a as shown in FIG. 7 .
- valves 52 a and 160 a can be placed in an open position so that syringe 132 a communicates with generator 24 a .
- generator 24 a is “on”, syringe 132 a will be filled with ozone.
- valves 52 a and 160 a can be placed in the closed position, and valve 40 a can be turned so that once apparatus 160 a is disconnected from valve 52 a , any ozone remaining in tubes 48 a , 36 a or elsewhere in that remaining portion of apparatus 24 a can be captured by scavenger 28 a.
- valve 160 a can then be selectively opened or closed to allow the administration of ozone to tissue, in much the same manner as previously described in relation to FIGS. 2 and 3 .
- Apparatus 20 b is a self-contained, portable version of apparatuses 20 and 20 a .
- apparatus 20 b includes a needle 164 b and a two-way valve 160 b that are substantially the same as needle 164 a and valve 160 a as described above.
- Apparatus 20 b also includes a syringe 132 b comprising a barrel 156 b (or other chamber) and a plunger 192 b (or other means to express the contents of the chamber).
- Plunger 192 b is configured as a normal plunger on a syringe, but also includes a miniature ozone generator 196 b mounted on the shaft of plunger 192 b .
- ozone generator 196 b is connected to a power supply 200 b and an on-off switch 204 b that is disposed on the exterior tip of the shaft of plunger 192 b .
- a small channel 208 b joins generator 196 b to the opposite tip of the shaft of plunger 192 b , such that when plunger 192 b is disposed in barrel 156 b , generator 196 b is in communication with the interior of barrel 156 b .
- switch 204 b can be activated and thereby cause ozone to be generated and fill barrel 156 b .
- ozone can be generated in either gaseous or liquid form.
- switch 204 b While switch 204 b is activated, it is generally desired to have valve 160 b placed in the closed position to prevent ozone from flowing from barrel 156 b into needle 164 b . Once a sufficient or otherwise desired amount of ozone has been generated and filled barrel 156 b , switch 204 b is turned “off” to discontinue generation of ozone, and then apparatus 20 b is used in much the same manner as administrator 32 as described above in relation to FIGS. 2 and 3 .
- the ozone generator 196 b can be provided in a variety of sizes, capable of delivering a range of ozone volumes, for example from about one cc to about five cc, but could be made to generate volumes of ozone liquid or gas form of about 0.1 cc to about one liter.
- Apparatus 20 c is a self-contained, implantable version of apparatuses 20 , 20 a and 20 b . As shown in FIG. 9 , apparatus 20 c is implanted subcutaneously proximal to hip 68 . In a present embodiment, apparatus 20 c includes a separate, external switchable power supply 212 c that is disposed just above the skin of the patient and is thereby activatable on demand by the patient. Power supply 212 c connects to a miniature ozone generator 196 c disposed percutaneously.
- generator 196 c is connected to an oxygen source 220 c , such that when power supply 212 c is “on”, generator 196 c will interact with source 220 c of either oxygen or sterile water, to generate ozone in either in liquid or gaseous form, inside a cavity 224 c .
- cavity 224 c is connected to a catheter 228 c , which interconnects with cavity 224 c with the tissue inside hip 68 to which the ozone is being administered to relieve pain associated therewith.
- power supply 212 c can be disposed subcutaneously, and a wireless switching means can be disposed on the outside of the patient, such as a magnetic switch or other types of wireless means for activating or deactivating the ozone generator.
- a wireless switching means can be disposed on the outside of the patient, such as a magnetic switch or other types of wireless means for activating or deactivating the ozone generator.
- an infusion wire 232 d is passed through needle 168 d until it coils inside nucleus pulposus 88 (or other tissue area for treatment.) Since infusion wire 232 d is perforated along its length, as shown in FIG. 14 , once a desired or sufficient amount of wire 232 d has been inserted into nucleus pulposus 88 , an ozone source can be connected to the opposite end of the infusion wire 232 d and injected into nucleus pulposus 88 via the infusion wire. Due to the perforations along infusion wire 232 d , ozone is dispersed more readily into nucleus pulposus 88 .
- FIG. 15 shows a syringe 132 e connected to a valve 160 e via tubing 232 e.
- kits of parts for performing an injection of medical ozone for the treatment of a herniated disc or the like includes a sterile tray with a number of compartments to hold:
- there is a method consisting of first introducing the patient into the computer tomography (“CT”) scanner and performing a diagnostic CT scan in order to identify the herniated disc such as disc 72 .
- CT computer tomography
- the CT gantry is subsequently draped and readied, the skin is prepared and local anesthetic is applied to the skin and adjacent soft tissue.
- a 16-18 G needle is pinned down to the disc level and a 22 G needle is inserted into the disc.
- a discogram is performed to check symptoms by injection of x-ray dye.
- the ozone apparatus (in the form of any of the previously described apparatus or such other apparatus as may now occur to those of skill in the art) is subsequently switched on and the ozone/oxygen concentration chosen.
- the ratio of ozone/oxygen mixtures to choose from are about 0 ⁇ g/ml, about 10 g/ml, about 20 ⁇ g/ml, about 30 ⁇ g/ml, about 40 ⁇ g/ml or about 50 ⁇ g/ml
- a presently preferred range is between about 10 ⁇ g/ml and about 34 ⁇ g/ml, but more preferably about 27 ⁇ g/ml to about 28 ⁇ g/ml.
- other gases or therapeutic agents can be used, such as pure oxygen if found to be therapeutically effective or desirable.
- the syringe is fitted with a disposable filtered attachment which is itself attached to 20-30 cm of non-compliant tubing fitted with a 3-way to cock on one end and a one-way stop cock on the other, such as that shown in FIG. 15 .
- Ozone gas is then aspirated into the 10-cc syringe (can also use a calibrated cardiac syringe) via the disposable filtered adapter and the connecting tubing such that the entire dead space is filled with a known concentration of ozone.
- the total volume of dead space should be known so appropriate amounts of ozone are actually injected to the desired area.
- CT fluoro imaging or the like can be subsequently used to inject the ozone into the disc and paraspinous soft tissues.
- An infusion wire with a stiff stylet could be used, as previously described.
- a stop cock on the connecting tubing is closed. All of the leftover ozone is injected into the charcoal scavenger or a pure oxygen tube/bottle attached to the connecting tubing via a Luer lock. Steroids are then injected through the coaxial outer large needle. Finally, all needles are removed, the skin is appropriately dressed and a bandage is used to cover the perforated skin.
- joints, tendons, ligaments are other areas that can be treated.
- Another example includes irrigating a wound site, such as a colostomy, with ozone to reduce pain at the wound site.
- an implantable device could put into the teeth (or other dental area) of a patient, similar to apparatus 20 c to reduce pain in the dental region.
- irrigate a subcutaneous pouch for holding a pacemaker or the like for sterilization and/or treatment of pain and/or decrease of inflammation and such other advantage corresponding to the therapeutic agent as will occur to those of skill in the art.
Abstract
Description
-
- i) irreversibility of the procedure
- ii) formation of scar tissue
- iii) slower recovery time
- iv) longer hospital stays
-
- fewer clinical and neuroradiological contraindications
- success rates greater than about 70% in the intervertebral disc
- little or no recovery time
- little or no side effects
- little or no scar tissue formed
- minimally invasive procedure in
- effective alternative treatment for which response to conservative management, such as rest and reduced daily activity, has failed to treat
-
- Disinfectant
- Drape
- Skin preparation material
- Local anaesthetics contained in vials
- Syringes
- Short and long needles, some with side holes
- Gantry drape
- Radiolucent needle holder
- Nonionic x-ray dye-for discogram
- Infusion wire
- Charcoal ozone scavenger
- Steroids contained in vials
- A source of ozone either generated as a gas or a liquid in a disposable single use unit that is sterilizable. The ozone can be generated in the delivery system as a battery powered electronic hand held disposable device
- The ozone generator based in the injector will be available in a variety of sizes, capable of delivering a range of ozone volumes, from 1 cc to 5 cc, but could be made to generate volumes of ozone liquid or gas form 0.1 cc to 1 liter.
- It is probable that the commonly used volumes would be between 1 cc and 10 cc allowing for dead space in the connecting tubing/needle etc.
- Disposable filtered attachment
- Stop cocks
- Non-compliant tubing
- Post-operative dressing for skin closure
- Adhesive bandages with gauze pad in the centre
-
- identifying the herniated disk with an imaging device;
- preparation of the skin above the affected area;
- applying local anaesthetics to the operation site;
- inserting a needle down to the disc level at the herniated disc;
- injecting nonionic x-ray dye down the needle;
- performing a discogram of the disc;
- activating an ozone generator external to the patient;
- selecting a specific concentration of O3/O2 gas mixture on the ozone generator;
- attaching a scavenger and a syringe to the ozone generator;
- aspirating the O3/O2 gas mixture into the syringe;
- injecting a predetermined volume of a fixed concentration of ozone/oxygen gas mixture into the disc and paraspinous soft tissues of the disc;
- capturing unused ozone in the charcoal scavenger; and,
- removing all needles;
- dressing the operative site.
-
- a disinfectant, drape and skin preparation material,
- lidocaine and a 10 cc syringe with a 22-G long needle,
- nonionic x-ray dye-for discogram such as Omnipaque 300 M,
- outer 16 or 18 G needle to act as the co-axial introducing needle,
- 20 or 22 G needle with possible side holes for injecting the ozone into the disc,
- outer large needle of 16-18 G for steroid injection (can also be used to inject ozone into the paraspinous soft tissue),
- an infusion wire for even distribution of the ozone into the disc space
- a charcoal ozone scavenger (a bottle with charcoal and 100% 02),
- steroids and local anaesthetics contained in a vial, ready for injection,
- a source of ozone such as a generator, examples include the AOS-1M Medical Ozonator or AOS-1MS Stainless Medical Ozonator, or a disposable injector in which then ozone can be generated filled with ozone,
- a disposable filtered attachment for the syringe a one way stop cock attached to the ozone generator,
- connecting, non-compliant tubing of 20-30 cm in length to reduce radiation to the operator hands during injection under image guidance.
- a three-way stop cock linking the tubing to the charcoal ozone scavenger bottle
- a one-way stop cock linking the tubing to the syringe via the said disposable filtered adapter,
- pharmaceutical gel such as Povidone, and
- adhesive bandages with a gauze pad in the center, such as Band-aid, or small dressing.
Claims (21)
Priority Applications (1)
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US12/430,740 US8162873B2 (en) | 2003-10-06 | 2009-04-27 | Apparatus for administering a therapeutic agent into tissue |
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US50830003P | 2003-10-06 | 2003-10-06 | |
US10/867,215 US7615030B2 (en) | 2003-10-06 | 2004-06-15 | Apparatus and method for administering a therapeutic agent into tissue |
US12/430,740 US8162873B2 (en) | 2003-10-06 | 2009-04-27 | Apparatus for administering a therapeutic agent into tissue |
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Application Number | Title | Priority Date | Filing Date |
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US10/867,215 Division US7615030B2 (en) | 2003-10-06 | 2004-06-15 | Apparatus and method for administering a therapeutic agent into tissue |
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US12/429,736 Abandoned US20090204062A1 (en) | 2003-10-06 | 2009-04-24 | Method for administering a therapeutic agent into tissue |
US12/430,740 Active US8162873B2 (en) | 2003-10-06 | 2009-04-27 | Apparatus for administering a therapeutic agent into tissue |
US12/431,062 Abandoned US20090209902A1 (en) | 2003-10-06 | 2009-04-28 | Kit for adminstering a therapeutic agent into tissue |
US12/431,089 Expired - Fee Related US8066695B2 (en) | 2003-10-06 | 2009-04-28 | Implantable apparatus for administering a therapeutic agent into tissue |
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Application Number | Title | Priority Date | Filing Date |
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US10/867,215 Active 2026-05-24 US7615030B2 (en) | 2003-10-06 | 2004-06-15 | Apparatus and method for administering a therapeutic agent into tissue |
US12/429,736 Abandoned US20090204062A1 (en) | 2003-10-06 | 2009-04-24 | Method for administering a therapeutic agent into tissue |
Family Applications After (2)
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US12/431,062 Abandoned US20090209902A1 (en) | 2003-10-06 | 2009-04-28 | Kit for adminstering a therapeutic agent into tissue |
US12/431,089 Expired - Fee Related US8066695B2 (en) | 2003-10-06 | 2009-04-28 | Implantable apparatus for administering a therapeutic agent into tissue |
Country Status (7)
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US (5) | US7615030B2 (en) |
EP (1) | EP1670526B1 (en) |
JP (2) | JP4734248B2 (en) |
AU (4) | AU2004277759B2 (en) |
CA (1) | CA2540447C (en) |
DE (3) | DE602004029210D1 (en) |
WO (1) | WO2005032387A2 (en) |
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AU2010206008B2 (en) | 2011-05-19 |
CA2540447A1 (en) | 2005-04-14 |
EP1670526A2 (en) | 2006-06-21 |
DE602004029210D1 (en) | 2010-10-28 |
US8066695B2 (en) | 2011-11-29 |
AU2010204469A1 (en) | 2010-08-19 |
AU2004277759A1 (en) | 2005-04-14 |
JP2011067648A (en) | 2011-04-07 |
US20090204062A1 (en) | 2009-08-13 |
US20090209901A1 (en) | 2009-08-20 |
AU2010204469B2 (en) | 2011-08-25 |
DE602004013027T2 (en) | 2009-05-14 |
JP5055417B2 (en) | 2012-10-24 |
AU2010206008A1 (en) | 2010-08-26 |
US20050074501A1 (en) | 2005-04-07 |
DE602004028532D1 (en) | 2010-09-16 |
US20090209902A1 (en) | 2009-08-20 |
AU2004277759B2 (en) | 2010-06-10 |
JP4734248B2 (en) | 2011-07-27 |
AU2010204467B2 (en) | 2012-08-23 |
US7615030B2 (en) | 2009-11-10 |
EP1670526B1 (en) | 2008-04-09 |
DE602004013027D1 (en) | 2008-05-21 |
US20090254021A1 (en) | 2009-10-08 |
JP2007507272A (en) | 2007-03-29 |
AU2010204467A1 (en) | 2010-08-19 |
WO2005032387A3 (en) | 2005-10-13 |
CA2540447C (en) | 2010-07-20 |
WO2005032387A2 (en) | 2005-04-14 |
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